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Clinical Trial Summary

The main objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels.

It will be a randomized crossover double-blind design conducted in 20 subjects.


Clinical Trial Description

Primary objective and outcome:

The primary objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels (WPM).

Secondary objectives and outcomes:

Explore the mechanism of action of WPM on thermogenesis including:

Protein turnover in response to the dose and the source of protein (WPM versus casein) Insulinemic and glycemic response to the dose and source of protein (WPM versus casein)

Design: The proposed study is a randomized double-blind, placebo-controlled, single center, crossover design.

At the start of the study, subjects will be randomly assigned to 4 different groups in a crossover design, where they will be asked to consume a beverage containing Product 1: 0g of protein (maltodextrin control) Product 2: 30g of WPM Product 3: 50g of WPM Product 4: 50g of micellar casein (MC) Number of subjects: The number of subjects will be 15. Sufficient subjects should be recruited to provide a 30% drop-out rate. Therefore 20 subjects will be needed including drop-outs. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT02303080
Study type Interventional
Source Nestlé
Contact
Status Completed
Phase N/A
Start date November 2010
Completion date December 2012

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